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NCT05512156

Toothbrushing Program in Saudi Arabia "TOPS"

Completed NA Last updated 27 April 2025
What this trial tests

NA trial testing Supervised Toothbrushing in Dental Caries in Children in 588 participants. Completed in 30 December 2024.

Timeline
18 September 2022
Primary endpoint
12 September 2024
30 December 2024

Quick facts

Lead sponsorUniversity of Glasgow
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment588
Start date18 September 2022
Primary completion12 September 2024
Estimated completion30 December 2024
Sites1 location across Saudi Arabia

Drugs / interventions tested

Conditions studied

Sponsor

University of Glasgow

Who can join

Adults 42 Months to 66 Months, any sex, with Dental Caries in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Project summary Introduction: Dental caries is a major oral health problem worldwide and is a particular public health challenge in Saudi Arabia. Dental caries cause pain, infection, and negatively impact quality of life. As part of population oral health improvement efforts in Saudi Arabia, this project aims to evaluate the effectiveness of a supervised toothbrushing programme in kindergartens. Aim: The aim of this project is to conduct a trial to assess the effectiveness of a supervised toothbrushing programme in kindergartens in Riyadh, Saudi Arabia . Methods: A cluster randomized controlled trial study will be undertaken in which the effectiveness of the daily supervised toothbrushing programme intervention running for two academic years will be randomly allocated to a sample of kindergartens in Riyadh and compared against treatment as usual which will be an annual oral health awareness visit in the control group of kindergartens over and above community water fluoridation. Effectiveness will be measured and delivered in terms of preventing dental caries in children when compared with children in the treatment as usual control group receiving the same level of community water fluoridation, but not the toothbrushing program intervention. All children in all kindergartens (both intervention and control groups) will have a dental examination (via trained and calibrated dental teams recording dental caries levels via dmft index) at baseline before intervention commences and at two academic years. In addition, questionnaires on behaviours and quality of life. In addition, process monitoring, and cost analysis surveys will be distributed. Research Questions: * Can such a supervised toothbrushing programme in kindergartens be effective at reducing the development of dental caries by 6 years of age? * Can a supervised toothbrushing programme in kindergartens in Saudi Arabia be established and implemented?

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Toothbrushing programme in Saudi Arabia 'TOPS': a study protocol for a cluster randomised controlled trial in kindergartens, Riyadh.
    Almutairi B, Conway D, Ross A, Hattan M, et al · · 2024 · PMID 39097315 · DOI 10.1136/bmjopen-2023-083504

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Other recruiting trials for Dental Caries in Children

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